Medical Device Manufacturer · US , West Valley City , UT

CenterPoint Systems, LLC

11 submissions · 11 cleared · Since 2021
11
Total
11
Cleared
0
Denied

CenterPoint Systems, LLC — FDA 510(k) Submissions

CenterPoint Systems, LLC has submitted 11 FDA 510(k) premarket notifications since 2021, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Percutaneous, Introducer, Catheter, Ureteroscope And Accessories, Flexible/rigid, Choledochoscope And Accessories, Flexible/rigid . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
AuST CSP Introducer
K260163 · DYB Introducer, Catheter · Cardiovascular
Feb 2026 30d
CPS Locator 3D Plus Delivery Catheter
K250828 · DQY Catheter, Percutaneous · Cardiovascular
Jun 2025 100d
FlexiGo 3D Delivery Catheter
K250492 · DQY Catheter, Percutaneous · Cardiovascular
Jun 2025 118d
AuST Steerable Sheath
K251051 · DYB Introducer, Catheter · Cardiovascular
Apr 2025 27d
SSPC NXT Delivery Catheter
K243180 · DQY Catheter, Percutaneous · Cardiovascular
Dec 2024 65d
AuST Steerable Sheath
K242106 · DYB Introducer, Catheter · Cardiovascular
Oct 2024 78d
Dragonfly? Pancreaticobiliary Scope; Dragonfly? Digital Controller; Dragonfly? Instrument Channel Caps
K233752 · FBN Choledochoscope And... · Gastroenterology & Urology
May 2024 162d
AuST Steerable Sheath
K240829 · DYB Introducer, Catheter · Cardiovascular
May 2024 36d
RenaNav Ureteroscope System
K223097 · FGB Ureteroscope And... · Gastroenterology & Urology
Jul 2023 304d
CPS Locator 3D Delivery Catheter
K230363 · DQY Catheter, Percutaneous · Cardiovascular
Mar 2023 27d
Guiding Catheter
K210009 · DQY Catheter, Percutaneous · Cardiovascular
Nov 2021 324d
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